check_circleStudy Completed

Anemia, Renal Insufficiency, Chronic

Bayer Identifier:

15141

ClinicalTrials.gov Identifier:

NCT02021370

EudraCT Number:

2013-001193-14

EU CT Number:

Not Available
15141 Fixed dose correction / naïve and pre dialysis (Europe and Asia Pacific)

Trial purpose

Anaemia is a condition in which blood has a lower than normal number of red blood cells. It can also occur if red blood cells do not contain enough haemoglobin, an oxygen carrying part of blood. Anaemia is common in patients with chronic kidney disease. Healthy kidneys produce a hormone called erythropoietin, which stimulates the bone marrow to produce the proper number of red blood cells needed to carry oxygen to vital organs. Chronic kidney disease is a general term that means that the kidneys are not functioning to their full potential. The study drug, BAY85-3934, is being evaluated as a drug to increase the body’s ability to produce erythropoietin.
The purpose of this study is to find out if the study drug, a tablet taken orally, is safe and effective for the treatment of anaemia associated with chronic kidney disease.
The study will enroll 120 patients at multiple locations in Europe, Asia and Australia. Participation will involve a screening visit and between 12 and 14 study visits scheduled over a period of approximately 5 to 7 months. The estimated total duration of study treatment will be 16 weeks. During these scheduled visits patients will undergo a number of procedures to confirm efficacy and safety of the study drug, including measurement of heart rate and blood pressure, physical examination, Electrocardiogram and blood/urine sample collection for laboratory tests.
The study will be conducted at 5 hospitals in the UK.
Bayer HealthCare AG is funding this research.

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - Women without childbearing potential
    - Male or female subjects ≥ 18 years of age with anemia of chronic kidney disease (CKD) at screening
    - Estimated glomerular filtration rate of < 60 mL/min/1.73 m2 (Modification of Diet in Renal Disease [MDRD] or the formula according to Matsuo, et al)
    - Not on dialysis and not expected to begin dialysis during the treatment period of the study (at least 16 weeks from randomization)
    - Not treated with any erythropoiesis-stimulating agent (ESA) within 8 weeks before randomization
    - Mean screening Hb concentration - Body weight of 45 kg to 125 kg, inclusive, at screening

  • - Subjects with significant acute or chronic bleeding, such as overt gastrointestinal bleeding
    - Chronic inflammatory disease that could impact erythropoiesis (e.g., systemic lupus erythematosis, rheumatoid arthritis, celiac disease) even if it is currently in remission
    - Previous or concurrent cancer except cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta, Tis, and T1) or any cancer curatively treated > 3 years prior to randomization
    - Subjects treated with any ESA within the 8 weeks before randomization
    - Red blood cell (RBC) containing transfusion within the 8 weeks before randomization
    - History of cardio- (cerebro-) vascular events (e.g., unstable angina, myocardial infarction, stroke, transient ischemic attack, deep vein thrombosis, pulmonary embolism) within the last 6 months from initial screening visit
    - Severe rhythm or conduction disorders (e.g., HR < 50 or > 110 bpm, atrial flutter, prolonged QT > 500 msec, third degree atrioventricular [AV] block)
    - New York Heart Association Class III or IV congestive heart failure
    - Severe hepatic insufficiency (defined as alanine aminotransferase [ALT] or aspartate aminotransferase [AST] > 3 x the upper limit of normal [ULN], total bilirubin > 2 mg/dL, or Child-Pugh B and C) or active hepatitis, in the investigator’s opinion

Trial summary

Enrollment Goal
121
Trial Dates
February 2014 - September 2015
Phase
Phase 2
Could I Receive a placebo
Yes
Products
Molidustat (BAY85-3934)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Pavia, 27100, Italy
Completed
Cremona, 26100, Italy
Withdrawn
Milano, 20132, Italy
Completed
Livorno, 57023, Italy
Withdrawn
Reservoir, 3073, Australia
Completed
Gosford, 2250, Australia
Completed
Melbourne, 3052, Australia
Withdrawn
London, United Kingdom
Completed
Cambridge, CB2 0QQ, United Kingdom
Withdrawn
Liverpool, L7 8XP, United Kingdom
Completed
London, SE5 9RS, United Kingdom
Completed
Doncaster, DN2 5LT, United Kingdom
Withdrawn
Nagano, 388-8004, Japan
Completed
Kitakyushu, 802-8555, Japan
Completed
Muroran, 050-0083, Japan
Completed
Fukuoka, 810-8563, Japan
Completed
Düsseldorf, 40210, Germany
Withdrawn
Pirmasens, 66953, Germany
Withdrawn
Berlin, 12053, Germany
Completed
Pecs, 7623, Hungary
Withdrawn
Debrecen, 4032, Hungary
Completed
Targu-Mures, 540103, Romania
Completed
Oradea, 410469, Romania
Withdrawn
Bucharest, 050098, Romania
Completed
Pazardjik, 4400, Bulgaria
Completed
Veliko Tarnovo, 5000, Bulgaria
Completed
Montana, 3400, Bulgaria
Completed
Lovech, 5500, Bulgaria
Withdrawn
Sofia, 1431, Bulgaria
Withdrawn
Sofia, 1527, Bulgaria
Completed
Bucheon-si, 420-767, Korea, Republic Of
Completed
Modena, 41100, Italy
Withdrawn
Chieti, 66013, Italy
Completed
Bucharest, 020475, Romania
Withdrawn
Fujisawa, 251-8550, Japan
Completed
Kamakura, 247-8533, Japan
Withdrawn
Bucharest, 010731, Romania
Completed
L'Hospitalet de Llobregat, 08907, Spain
Withdrawn
Alicante, 03010, Spain
Withdrawn
Córdoba, 14004, Spain
Withdrawn
Burgas, 8000, Bulgaria
Completed
Baja, 6500, Hungary
Withdrawn
PIERRE BENITE CEDEX, 69495, France
Withdrawn
PARIS CEDEX 15, 75908, France
Withdrawn
GRENOBLE CEDEX 9, 38043, France
Withdrawn
PERPIGNAN CEDEX 9, 66046, France
Withdrawn
MARSEILLE CEDEX 5, 13385, France
Withdrawn
REIMS cedex, 51092, France
Completed
Constanta, 900591, Romania
Completed
Kuwana, 511-0061, Japan
Completed
Stara Zagora, 6000, Bulgaria
Completed
Gabrovo, 5300, Bulgaria
Withdrawn
Kaposvar, 7400, Hungary
Withdrawn
Szigetvar, 7900, Hungary
Completed
Okawa, 831-0016, Japan
Completed
Poznan, 61-858, Poland
Completed
Radom, 26-610, Poland
Withdrawn
Valenciennes, 59300, France
Completed
LIMOGES Cedex1, 87042, France
Withdrawn
BREST CEDEX, 29609, France
Withdrawn
Wuppertal, 42283, Germany
Completed
Bialystok, 15-540, Poland
Completed
Chiba, 260-8712, Japan
Completed
Szczecin, 70-111, Poland
Completed
Bonn, 53127, Germany
Completed
Seoul, 156-707, Korea, Republic Of
Completed
Seoul, 156-755, Korea, Republic Of
Completed
Seoul, 03080, Korea, Republic Of
Completed
Zyrardow, 96-300, Poland
Completed
Malbork, 82-200, Poland
Completed
Halle (Saale), 06097, Germany
Completed
Hakusan, 924-8588, Japan
Completed
Nara, 630-8581, Japan
Completed
Morioka, 020-0066, Japan
Withdrawn
Milano, 20162, Italy
Completed
Napoli, 80138, Italy
Withdrawn
Kfar Saba, 4428164, Israel
Completed
Ashkelon, 7827804, Israel
Withdrawn
Dobrich, 9300, Bulgaria
Withdrawn
Brescia, 25123, Italy
Completed
Hadera, 3810101, Israel
Completed
Nahariya, 2210001, Israel
Withdrawn
Jerusalem, 9112001, Israel
Terminated
Ankara Univ. Medical FacultyAnkara, 06100, Turkey
Terminated
Baskent University Medical FacultyAnkara, 06490, Turkey
Terminated
Sifa University Medical FacultyIZMIR, 03540, Turkey
Withdrawn
Salford, M6 8HD, United Kingdom
Completed
Budapest, 1036, Hungary
Withdrawn
Sofia, 1872, Bulgaria
Withdrawn
Karlovo, 4300, Bulgaria
Completed
Villingen-Schwenningen, 78052, Germany
Withdrawn
San Dimas, 91773, United States
Withdrawn
Lynwood, 90262, United States
Withdrawn
Ontario, 90022, United States
Withdrawn
Chorley, PR7 7NA, United Kingdom
Withdrawn
Hexham, NE46 1QJ, United Kingdom
Withdrawn
Manchester, M15 6SX, United Kingdom
Withdrawn
Glasgow, G20 OSP, United Kingdom
Completed
Santiago de Compostela, 15706, Spain
Withdrawn
Liverpool, L22 0LG, United Kingdom
Withdrawn
Birmingham, B15 2SQ, United Kingdom
Withdrawn
Reading, RG2 0TG, United Kingdom

Primary Outcome

  • Change in local laboratory hemoglobin level from baseline to the average during the last 4 weeks treatment period
    date_rangeTime Frame:
    Baseline and week 12 to 16
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Change in local laboratory hemoglobin level from baseline
    date_rangeTime Frame:
    Baseline up to 12 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Speed of change in hemoglobin level per unit time
    date_rangeTime Frame:
    Up to 16 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Duration of treatment exposure
    date_rangeTime Frame:
    Up to 16 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Number of participants with serious adverse events as a measure of safety and tolerability
    date_rangeTime Frame:
    Up to 16 weeks
    enhanced_encryption
    Safety Issue:
    Yes
  • Pharmacodynamics characterized by erythropoietin concentration
    date_rangeTime Frame:
    Several time points up to 16 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Pharmacodynamics characterized by reticulocyte count
    date_rangeTime Frame:
    Several time points up to 16 weeks
    enhanced_encryption
    Safety Issue:
    No

Trial design

A randomized, placebo-controlled, double-blind, parallel group, multicenter study to investigate the efficacy and safety of 5 fixed doses of BAY85-3934 administered orally in the correction of anemia in pre-dialysis subjects with chronic kidney disease not currently treated with erythropoiesis-stimulating agent in Europe and Asia Pacific
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
6

Additional Information

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